MIDSTREAM COLLECTION KIT
Device Facts
| Record ID | K800947 |
|---|---|
| Device Name | MIDSTREAM COLLECTION KIT |
| Applicant | Sage Products, Inc. |
| Product Code | FMH · Pathology |
| Decision Date | May 30, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.3250 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
